- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563654
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
June 15, 2011 updated by: Hospital Authority, Hong Kong
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With Acute Urinary Retention With Long Term Follow up
The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, China
- North District Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Aged 50 or above
- Admitted for AUR due to BPH with PVR of 500 ml or more
Exclusion Criteria:
- Previous history of TURP
- Use of alpha blockers within recent 8 months
- Renal impairment (serum creatinine >140 umol/l)
- Poor premorbid state
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Successful rate of Trial Without Catheter (TWOC) at phase 1
Time Frame: At discharge after TWOC (at the end phase one)
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At discharge after TWOC (at the end phase one)
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Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
Time Frame: From the end of phase one to eight months after successful TWOC (the end of phase 2)
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From the end of phase one to eight months after successful TWOC (the end of phase 2)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
Time Frame: From the time of treatment drug administration to the end of phase 1
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From the time of treatment drug administration to the end of phase 1
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Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
Time Frame: At the end of phase I (discharge after TWOC) and at the end of phase 2
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At the end of phase I (discharge after TWOC) and at the end of phase 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chi Wai Cheng, Dr, Department of Surgery, Division of Urology, North District Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 21, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Prostatic Diseases
- Urination Disorders
- Prostatic Hyperplasia
- Hyperplasia
- Acute Disease
- Urinary Retention
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Alfuzosin
Other Study ID Numbers
- CRE-2005.332
- HARECCTR0500048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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